Website The Biovac Institute
The Biovac Institute requires a QA Administrator to contribute to its mission of establishing local biological and vaccine manufacturing capability at its Cape Town based site. Being the only one of its kind in South Africa, Biovac strives to respond to the vaccine needs of the developing countries, specifically South Africa and Sub-Saharan Africa. This is a particularly exciting time for the company as it continues to grow, strengthen and build on its success and further develop its capabilities, products, services and market diversification.
The successful incumbent will report to the Section Head: QA Systems.
The Key Performance Areas for this position include:
- Responsible for administrative activities including but not limited to:
– To provide administrative assistance and support related to the Quality Assurance areas.
– Participation in quality audits and support to teams.
– Effective implementation / maintenance of quality systems & safety systems.
- Document Administration with Pharmaceutical Quality System documents.
- Record Administration, archiving, and filing of documents.
- Coordinate document / software sign-out and retrieval: archive.
- Mastering and extension of documents.
- Batch number and batch document issuing.
- Batch book retrieval.
- Report generation: Overdue documents.
- General Administration including filing (electronically and hard copies), scanning, assisting in audits, minute- taking, etc.
- Generating Purchase requisitions, liaison with Procurement, collation and processing of expense claims and coordination of department requirements e.g. stationery and events.
- Measurement, Analysis and Improvement Initiatives: Data capture, analysis, and assist in cross-functional projects.
- Backup and assistance to in other departments, as agreed e.g. documentation officers, compliance officers.
Technical Competencies required to perform this aspect of the role:
- Computer Literacy
- cGMP knowledge
- Total Quality Management & Quality Management Systems
- Data development, trending & reporting
- Standard Operating Procedures
- Quality management systems
Generic Competencies required
- Planning, Organising, execution and monitoring
- Creative problem solving skills
- Internal stakeholder management
- Action & Results Oriented
- Assertive & Resilient
- Ability to multi task
- Influencing skills
- Clear, timely and effective communication skills both verbally and in writing
Supporting Quality Management
- Building own cGMP knowledge and compliance
- Participate in achieving the company’s quality objectives.
- Participate in building a sustainable quality culture on site and proactive mitigate risks that may negatively impact quality or escalate these appropriately.
- Ensuring audit readiness within own role through closing out audit findings timeously
- Ensure Deviations, Change Controls, CAPAs are handled effectively
- Advocate continuous improvement
Knowledge & Experience
- At least 1 years’ experience within the pharmaceutical/ vaccine manufacturing / quality assurance or similar position
- Experience in quality management systems within a cGMP facility
- Knowledge of Pharmaceutical related legislation
- Experience in managing databases
- Previous participation in quality audits will be an advantage
- Experience in aseptic (sterile) manufacturing
Matric/ Grade 12 or equivalent.
Recognition is given to Prior Learning and practical experience.
Advanced Excel and Power Point
Potential shift work, own reliable transport, ability to conduct road and air travel nationally and internationally
All positions will be filled in accordance with our Employment Equity policy as The Biovac Institute is committed to the pursuit of excellence, diversity and redress.
Interested persons to kindly submit their CV’s to email@example.com by 31 May 2018
Kindly note that by submitting your application for this career opportunity you agree that Biovac may use your application for the purpose of the recruitment and selection of the said position and this information may be shared with the relevant stakeholders in the business